Introduction and rational use of new drugs/regimens for the treatment of tuberculosis in countries

Background

WHO/Nick Otto

Much progress has been made in research and development of new drugs for TB over the last decade. A series of Phase II and III trials of shortened treatment of drug-sensitive TB including repurposed drugs (eg. fluoroquinolones) or new dosages of known drugs (eg. rifamycin, rifapentine) are presently on-going, with earliest results expected in 2013. Two novel drugs are being evaluated in Phase IIb and III trials for the treatment of multi-drug resistant (MDR) TB, and dossiers have been submitted to regulatory authorities for authorization of licensure. Lastly, novel drug combinations for shortened treatment of drug-sensitive (DS) and/or drug-resistant (DR) TB, including new or re-purposed drugs, are under investigation.

The likely introduction of new drugs or drug regimens for the treatment of DS- or DR-TB will have a series of public health implications, particularly regarding:

the responsible use of new drugs as part of set combination regimens for the treatment of DS- and/or DR-TB;

the programmatic feasibility and cost-effectiveness of newly-developed treatments;

the capacity to monitor scaled-up use of new drugs, and conduct surveillance of drug-resistance;

the prevention of emergence of new drug resistance.

In this context, the WHO Strategic and Technical Advisory Group on Tuberculosis (STAG-TB) endorsed in June 2012 a plan to develop necessary policy guidance for the introduction and use of new TB drugs within recommended regimens. The plan also calls for WHO to support the optimal uptake of new TB drugs/regimens, once results of drug trials become available and drugs are granted license for market access by regulatory authorities, and foster the optimal uptake and rational use of new TB drugs within defined regimens in programmatic conditions.